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Prospective observational cohort study on the efficacy and safety of Evodia Radix Recipe in the treatment of chronic non-atrophic gastritis

注册号：

Registration number：

ITMCTR2200006408

最近更新日期：

Date of Last Refreshed on：

2022-08-01

注册时间：

Date of Registration：

2022-08-01

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

吴茱萸类方治疗慢性非萎缩性胃炎的有效性及安全性评价前瞻性观察性队列研究

Public title：

Prospective observational cohort study on the efficacy and safety of Evodia Radix Recipe in the treatment of chronic non-atrophic gastritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于临床病证结合的吴茱萸类方减毒增效配伍评价及生物学基础研究

Scientific title：

Compatibility evaluation and biological basis of Evodia Fructus Recipe based on combination of clinical disease and syndrome

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

ChiCTR2200062296 ; ChiMCTR2200006408

申请注册联系人：

景漫毅

研究负责人：

赵艳玲

Applicant：

Manyi Jing

Study leader：

Yanling Zhao

申请注册联系人电话：

Applicant telephone：

13552816266

研究负责人电话：

Study leader's telephone：

13681208998

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

jingmanyi@yeah.net

研究负责人电子邮件：

Study leader's E-mail：

zhaoyl2855@126.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

北京市丰台区西四环中路 100 号

研究负责人通讯地址：

北京市丰台区西四环中路 100 号

Applicant address：

No. 100, Middle West Fourth Ring Road, Fengtai District, Beijing

Study leader's address：

No. 100, Middle West Fourth Ring Road, Fengtai District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中国人民解放军总医院

Applicant's institution：

Chinese People's Liberation Army General Hospital

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

KY-2022-2-6-1

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

中国人民解放军总医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Chinese People's Liberation Army General Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2022/2/15 0:00:00

伦理委员会联系人：

李素娟

Contact Name of the ethic committee：

Sujuan LI

伦理委员会联系地址：

北京市丰台区东大街 8 号

Contact Address of the ethic committee：

No. 8 East Street, Fengtai District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

解放军总医院第五医学中心

Primary sponsor：

Fifth Medical Center of PLA General Hospital

研究实施负责（组长）单位地址：

北京市丰台区西四环中路 100 号

Primary sponsor's address：

No. 100, Middle West Fourth Ring Road, Fengtai District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

丰台区

Country：

China

Province：

Beijing

City：

Fengtai District

单位(医院)：

解放军总医院第五医学中心

具体地址：

北京市丰台区西四环中路 100 号

Institution
hospital：

Fifth Medical Center of PLA General Hospital

Address：

No. 100, Middle West Fourth Ring Road, Fengtai District, Beijing

经费或物资来源：

国家自然科学基金重大项目

Source(s) of funding：

National Natural Science Foundation of China major project

研究疾病：

慢性非萎缩性胃炎

研究疾病代码：

Target disease：

Chronic non-atrophic gastritis

Target disease code：

研究类型：

Study type：

观察性研究

Observational study

研究设计：

Study design：

析因分组（即根据危险因素或暴露因素分组）

Factorial

研究所处阶段：

Study phase：

其它

Others

研究目的：

阐明吴茱萸类方在“病证结合”背景下减毒增效配伍的科学内涵，形成适用于临床的早期毒性预警敏感指标。

Objectives of Study：

To clarify the scientific connotation of the combination of Evodia Fructus in the context of "combination of disease and syndrome", and to form a sensitive indicator for early toxicity early warning in clinic.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

① 年龄18～65岁，男女不限； ② 西医诊断为慢性非萎缩性胃炎； ③ 中医证候辨证为肝火犯胃证或肝胃虚寒证； ④ 育龄受试者在试验期间自愿做有效避孕措施者； ⑤ 自愿签署知情同意书。

Inclusion criteria

① Age 18 to 65 years old, male or female; ② Western medicine diagnosed as chronic non-atrophic gastritis; ③ TCM syndrome differentiation is the liver-fire invading stomach syndrome or liver-stomach deficiency-cold syndrome; ④ Subjects of childbearing age who voluntarily take effective contraceptive measures during the trial; ⑤ Voluntarily signed the informed consent.

排除标准：

① 胃镜检查有食管疾病、消化性溃疡、肿瘤、出血病变者； ② 合并胃黏膜重度异型增生及病理诊断疑有恶变者； ③ 经血清胃泌素、维生素B12 水平和相关自身抗体（抗壁细胞抗体和抗内因子抗体）排除自身免疫性胃炎患者； ④ 具有严重的原发性心、肝、肺、肾、血液或影响其生存的严重疾病，如肿瘤、艾滋病或凝血障碍等； ⑤ 实验室检查：Scr＞N（N为正常值上限）；ALT、AST＞N；血白细胞＜3.0×109/L； ⑥ 过敏体质，如对药物或食物过敏者；或已知对研究药物过敏者； ⑦ 酗酒、药物依赖患者，有癫痫病史或伴有精神障碍患者； ⑧ 妊娠、哺乳期妇女或计划妊娠者； ⑨ 3个月内曾参加过或正在参加其他临床试验者； ⑩ 研究者认为不适宜受试的其他患者。

Exclusion criteria：

① Gastroscopy with esophageal disease, peptic ulcer, tumor, bleeding lesions; ② Combined with severe dysplasia of gastric mucosa and pathological diagnosis of suspected malignant transformation; ③ Patients with autoimmune gastritis were excluded by serum gastrin, vitamin B12 levels and related autoantibodies (anti-parietal cell antibodies and anti-intrinsic factor antibodies); ④ Have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival, such as tumors, AIDS or coagulation disorders; ⑤ Laboratory examination: Scr>N (N is the upper limit of normal value); ALT, AST>N; white blood cells <3.0×109/L; ⑥ Allergic constitution, such as those who are allergic to drugs or food; or those who are known to be allergic to research drugs; ⑦ Patients with alcoholism and drug dependence, with a history of epilepsy or with mental disorders; ⑧ Pregnant, lactating women or those planning to become pregnant; ⑨ Those who have participated in or are participating in other clinical trials within 3 months; ⑩ Other patients deemed unsuitable for the study by the investigator.

研究实施时间：

Study execute time：

从From 2022-03-01

至To      2025-03-01

征募观察对象时间：

Recruiting time：

从From 2022-08-01

至To      2025-03-01

干预措施：

Interventions：

组别：

胃热证

样本量：

475

Group：

Stomach heat syndrome

Sample size：

干预措施：

左金丸

干预措施代码：

Intervention：

Zuojin pill

Intervention code：

组别：

胃寒证

样本量：

475

Group：

Stomach cold syndrome

Sample size：

干预措施：

吴茱萸汤

干预措施代码：

Intervention：

Wuzhuyu decoction

Intervention code：

样本总量 Total sample size ： 950

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京市

市(区县)：

丰台区

Country：

China

Province：

Beijing

City：

Fengtai District

单位(医院)：

解放军总医院第五医学中心

单位级别：

三级甲等

Institution/hospital：

Fifth Medical Center of PLA General Hospital

Level of the institution：

Tertiary A class

国家：

中国

省(直辖市)：

北京市

市(区县)：

海淀区

Country：

China

Province：

Beijing

City：

Haidian District

单位(医院)：

解放军总医院第六医学中心

单位级别：

三级甲等

Institution/hospital：

Sixth Medical Center of PLA General Hospital

Level of the institution：

Tertiary A class

国家：

中国

省(直辖市)：

北京市

市(区县)：

西城区

Country：

China

Province：

Beijing

City：

Xicheng District

单位(医院)：

中国中医科学院广安门医院

单位级别：

三级甲等

Institution/hospital：

Guang'anmen hospiital of China academy of Chinese medical sciences

Level of the institution：

Tertiary A class

测量指标：

Outcomes：

指标中文名：

临床观察性指标

指标类型：

主要指标

Outcome：

Clinical observational indicators

Type：

Primary indicator

测量时间点：

治疗前和治疗后

测量方法：

临床观察

Measure time point of outcome：

Before and after treatment

Measure method：

Clinical Observation

指标中文名：

组织病理学检查结果

指标类型：

次要指标

Outcome：

Histopathological findings

Type：

Secondary indicator

测量时间点：

治疗前和治疗后

测量方法：

组织病理

Measure time point of outcome：

Before and after treatment

Measure method：

Histopathology

指标中文名：

肝损伤指标

指标类型：

主要指标

Outcome：

Liver damage indicators

Type：

Primary indicator

测量时间点：

治疗前和治疗后

测量方法：

临床症状及体征、生化检查结果

Measure time point of outcome：

Before and after treatment

Measure method：

Clinical symptoms and signs, biochemical test results

指标中文名：

肾损伤指标

指标类型：

主要指标

Outcome：

Kidney damage indicators

Type：

Primary indicator

测量时间点：

治疗前和治疗后

测量方法：

生化检查结果

Measure time point of outcome：

Before and after treatment

Measure method：

Biochemical test results

指标中文名：

中医证候积分

指标类型：

次要指标

Outcome：

TCM syndrome score

Type：

Secondary indicator

测量时间点：

治疗前和治疗后

测量方法：

中医辨证

Measure time point of outcome：

Before and after treatment

Measure method：

TCM Syndrome Differentiation

指标中文名：

神经损伤评价指标

指标类型：

主要指标

Outcome：

Nerve damage evaluation index

Type：

Primary indicator

测量时间点：

治疗前和治疗后

测量方法：

临床症状及体征

Measure time point of outcome：

Before and after treatment

Measure method：

Clinical symptoms and signs

指标中文名：

内源代谢物

指标类型：

次要指标

Outcome：

Endogenous metabolites

Type：

Secondary indicator

测量时间点：

治疗前和治疗后

测量方法：

代谢组学、转录组学和微生物组学

Measure time point of outcome：

Before and after treatment

Measure method：

Metabolomics, Transcriptomics and Microbiomics

指标中文名：

临床疗效指标

指标类型：

次要指标

Outcome：

Clinical efficacy indicators

Type：

Secondary indicator

测量时间点：

治疗前和治疗后

测量方法：

临床观察

Measure time point of outcome：

Before and after treatment

Measure method：

Clinical Observation

指标中文名：

胃镜检查结果

指标类型：

次要指标

Outcome：

Gastroscopy results

Type：

Secondary indicator

测量时间点：

治疗前和治疗后

测量方法：

胃镜检查

Measure time point of outcome：

Before and after treatment

Measure method：

Gastroscopy

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

血液

Sample Name：

Blood

Tissue：

Blood

人体标本去向

使用后销毁

说明

用于血常规、肝肾功能和代谢组学检测

Fate of sample 

Destruction after use

Note：

For blood routine, liver and kidney function and metabolomics detection

标本中文名：

粪便

组织：

粪便

Sample Name：

Stool

Tissue：

Stool

人体标本去向

使用后销毁

说明

用于大便常规和肠道菌群检测

Fate of sample 

Destruction after use

Note：

For stool routine and intestinal flora detection

标本中文名：

胃粘膜

组织：

胃黏膜

Sample Name：

Gastric mucosa

Tissue：

Gastric mucosa

人体标本去向

使用后销毁

说明

用于组织病理检测和转录组学检测

Fate of sample 

Destruction after use

Note：

For histopathological and transcriptomic assays

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究不涉及随机对照设计

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study does not involve a randomized controlled design

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

否

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

本研究将公开发表学术论文

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

This research will be published in academic papers

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

1 数据管理 数据管理具体要求见“数据管理计划书”，本方案仅涵盖数据管理的一般要求。 1.1 eCRF建立 本试验采用电子化数据管理系统进行试验数据的采集与管理，数据管理系统由迈玛思特（北京）信息技术有限公司进行开发和维护。 设计eCRF前应首先制定注释CRF及eCRF设计说明，注释CRF需在CRF相应的数据栏标明变量名，数据变量命名应当符合CFDA现行要求，并尽量符合CDISC要求。除此之外，注释CRF/eCRF设计说明应至少包括变量所属数据集、变量名和标签、变量类型、变量格式与长度、变量赋值范围。 eCRF设计按既定的注释CRF及eCRF设计说明执行。数据库系统具备对操作及修改记录的稽查轨迹功能，且严格执行数据管理单位相关SOP。制定数据录入说明，要求数据录入和修正人员按录入说明保证录入准确和完整。 EDC通过测试并获申办方或申办方授权者批准后发布使用；各角色权限人员PI、Sub-I、CRC、PM、CRA、DM等经过培训后方可正式上线应用。 1.2 数据的采集和录入 在源文件中收集到的数据将由各中心研究者及时、完整、正确、清晰地载入研究病历中，然后由研究者或经授权的数据录入员直接录入本研究的eCRF中。各中心的研究者应确保提交到eCRF中数据的准确性、完整性和及时性。 监查员（CRA）监查试验的进行是否遵循试验方案。确认所有研究病历填写正确并与原始资料一致。如有错误和遗漏，及时要求研究者改正。修改时需保持原有记录清晰可见，改正处需经研究者签名并注明日期。 对于完成的研究病历在研究者、监查员、数据录入员之间的传送应有专门的记录，收到时应有相应的签名，记录需妥善保存。 数据录入员录入数据采用一次录入。录入过程发现问题或意外情况，应做好登记并及时报告，以便迅速处理问题。数据录入后，由监查员进行100%源数据核查（SDV）。 1.3 数据审核和质疑处理 监查员负责中心现场监查，100% 的核对eCRF录入是否正确、完整，且与原始病历和实验室检查报告单等原始文件是否一致，发现问题可随时在线发出疑问。 数据管理人员依据数据核查计划(DVP)对试验数据进行质疑管理。 数据录入EDC系统时，如有不符合逻辑的数据，系统会自动进行核查并出疑问(Query)；这些Query需要研究者或经过授权的人员进行审核并回答。 除系统自动核查外，通过SAS编程或数据管理员人工核查出的疑问，当需要研究者澄清/核实/确认时，可在EDC系统上面手工添加Query。 研究者需及时解答疑问。数据管理员、监查员、医学人员进行疑问批复，必要时可再次发出疑问，直至数据“清洁”。 1.4 研究者签名 数据管理员需确认所有的Query都清理干净，研究者进行电子签名审核确认。签名后的如有数据修订，需重新签名。 1.5 医学编码 医学编码员进行医学编码工作。编码内容包括合并用药与不良事件。不良事件将根据MedDRA（17.0或以上版本）词典进行编码，合并用药采用WHO ATC进行编码。 编码过程中，任何由于医学术语提供不当，不准确，模糊而导致的无法编码，DM可以在线实时质疑给研究者。 数据库锁定前，研究者对医学编码进行审核。 1.6 数据锁定及导出 完成数据锁库清单，依据数据库锁定的程序，由数据管理人员、统计分析人员、临床监查员代表、研究者代表等签署书面批准数据库锁定文件，由数据管理员将其导出指定格式的数据库，交与统计人员进行统计分析，锁定后的数据不可再编辑。数据锁定后如有确切证据证明有必要解锁，研究者及相关人员需签署解锁文件。 1.7 eCRF存档 试验结束，每个受试者的eCRF导出PDF进行电子存档，刻录光盘保存在临床试验单位，保存期限至试验完成后至少5年。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1 Data management For the specific requirements of data management, please refer to the "Data Management Plan", this plan only covers the general requirements of data management. 1.1 eCRF establishment In this experiment, an electronic data management system was used to collect and manage the experimental data, and the data management system was developed and maintained by MyMaster (Beijing) Information Technology Co., Ltd. Before designing an eCRF, an annotated CRF and an eCRF design description should be formulated first. Annotated CRF should indicate the variable name in the corresponding data column of the CRF. The data variable naming should conform to the current requirements of CFDA, and to meet the requirements of CDISC as much as possible. In addition, the annotated CRF/eCRF design description should at least include the data set to which the variable belongs, variable name and label, variable type, variable format and length, and variable assignment range. The eCRF design is performed according to the established Annotated CRF and eCRF Design Specifications. The database system has the function of checking the operation and modification records, and strictly implements the relevant SOP of the data management unit. Develop data entry instructions and require data entry and correction personnel to ensure accurate and complete entry according to the entry instructions. EDC is released for use after passing the test and being approved by the sponsor or the sponsor's authorizer; the PI, Sub-I, CRC, PM, CRA, DM, etc. of each role's authorized personnel can be officially launched and applied after training. 1.2 Data collection and entry The data collected in the source files will be recorded in the study medical records in a timely, complete, correct and clear manner by the investigators of each center, and then directly entered into the eCRF of this study by the investigators or authorized data entry personnel. Investigators at each center should ensure the accuracy, completeness, and timeliness of data submitted to the eCRF. A supervisor (CRA) monitors the conduct of the trial for adherence to the trial protocol. Verify that all study medical records are filled out correctly and consistent with the original data. If there are any errors or omissions, the researchers should be promptly requested to correct them. The original records should be kept clear and visible during revisions, and the corrections should be signed and dated by the researcher. There should be special records for the transmission of completed research medical records among investigators, supervisors, and data entry personnel, and corresponding signatures should be given upon receipt, and the records should be properly kept. Data entry personnel enter data using one-time entry. If problems or unexpected situations are found in the input process, they should be registered and reported in time so that the problems can be dealt with quickly. After data entry, a 100% source data verification (SDV) was performed by the monitor. 1.3 Data review and challenge handling The inspector is responsible for the on-site inspection of the center, and 100% checks whether the eCRF entry is correct and complete, and whether it is consistent with the original documents such as the original medical record and laboratory inspection report. The data management personnel conduct challenge management on the trial data according to the data verification plan (DVP). When data is entered into the EDC system, if there is illogical data, the system will automatically check and ask questions (Query); these queries need to be reviewed and answered by researchers or authorized personnel. In addition to the automatic verification of the system, questions that are manually verified by SAS programming or data administrators can be manually added to the EDC system when the researcher needs to clarify/verify/confirm. Researchers need to answer questions in a timely manner. Data administrators, supervisors, and medical staff will reply to questions, and if necessary, they can issue questions again until the data is "clean." 1.4 Investigator Signature The data administrator needs to confirm that all queries are cleaned up, and the researcher conducts an electronic signature review for confirmation. If there is any data revision after signing, it needs to be re-signed. 1.5 Medical Coding Medical coders perform medical coding jobs. The coding content includes concomitant medications and adverse events. Adverse events will be coded according to the MedDRA (version 17.0 or above) dictionary, and concomitant medications will be coded using the WHO ATC. During the coding process, if any medical term cannot be coded due to inappropriate, inaccurate, or vague provision of medical terms, the DM can challenge the researcher online in real time. Before the database was locked, the researchers reviewed the medical codes. 1.6 Data Lock and Export Complete the data lock library list, according to the database lock procedure, the data management personnel, statistical analysts, clinical monitor representatives, researcher representatives, etc. sign and approve the database lock file in writing, and the data administrator will export it to the database in the specified format. Submit it to the statistician for statistical analysis, and the locked data cannot be edited. After the data is locked, if there is definite evidence that it is necessary to unlock the data, the researchers and relevant personnel need to sign the unlocking document. 1.7 eCRF Archive At the end of the trial, the eCRF of each subject is exported to PDF for electronic archiving, and the CD-ROM is stored in the clinical trial unit for at least 5 years after the completion of the trial.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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